Hydrocodone and acetaminophen

Adrenal Insufficiency Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible.

If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers. Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency.

The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency. Severe Hypotension Hydrocodone bitartrate and acetaminophen oral solution may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics) [see PRECAUTIONS; Drug Interactions ].

DOSAGE AND ADMINISTRATION . Important Dosage and Administration Instructions Ensure accuracy when prescribing, dispensing, and administering hydrocodone bitartrate and acetaminophen oral solution to avoid dosing errors due to confusion between mg and mL, and with other hydrocodone bitartrate and acetaminophen oral solutions of different concentrations, which could result in accidental overdose and death.

Ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume. Instruct patients and caregivers on how to accurately measure and take the correct dose of hydrocodone bitartrate and acetaminophen oral solution. Strongly advise patients and caregivers to always use a graduated oral syringe or measuring cup, with metric units of measurements (i.e., mL) to correctly measure the prescribed amount of medication.

Inform patients and caregivers that oral dosing devices may be obtained from their pharmacy and to never use household teaspoons or tablespoons to measure hydrocodone bitartrate and acetaminophen oral solution. Hydrocodone bitartrate and acetaminophen oral solution should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks.

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS ]. Because the risk of overdose increases as opioid doses increase, reserve titration to higher doses of hydrocodone bitartrate and acetaminophen oral solution for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher does opioid clearly outweigh the substantial risks.

Initiate the dosing regimen for each patient individually; taking into account the patient's underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse [see WARNINGS ]. Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with hydrocodone bitartrate and acetaminophen oral solution.

There are important differences among the opioid overdose reversal agents, such as route of administration, product strength, approved patient age range, and pharmacokinetics. Be familiar with these differences, as outlined in the approved labeling for those products, prior to recommending or prescribing such an agent. Initial Dosage Use of Hydrocodone Bitartrate and Acetaminophen Oral Solution as the First Opioid Analgesic Hydrocodone bitartrate and acetaminophen oral solution contains 10 mg of hydrocodone bitartrate and 300 mg of acetaminophen per 15 mL.

Initiate treatment with hydrocodone bitartrate and acetaminophen oral solution at a dose of 11.25 milliliters (equivalent to 7.5 mg hydrocodone bitartrate) every 4 to 6 hours as needed for pain. Titrate the dose based upon the individual patient’s response to their initial dose of hydrocodone bitartrate and acetaminophen oral solution.

These dosages correspond to an average individual dose of 0.20 mL/kg of hydrocodone bitartrate and acetaminophen oral solution (providing 0.135 mg/kg of hydrocodone bitartrate and 4 mg/kg of acetaminophen). Dosing should be based on weight whenever possible. However, for pediatric patients weighing 101 lbs. (46 kg) and up, do not exceed the total daily dose of 67.5 mL (45 mg hydrocodone bitartrate) and do not exceed a single dose greater than 11.25 mL (7.5 mg hydrocodone bitartrate).

Doses above these amounts would exceed the maximum doses for adults. It is of utmost importance that the dose of hydrocodone bitartrate and acetaminophen oral solution be administered accurately [see DOSAGE AND ADMINISTRATION ; Important Dosage and Administration Instructions ]. [See table below.] * For pediatric patients weighing 101 lbs (46 kg) and up, do not exceed the total daily dose of 67.5 mL (45 mg hydrocodone bitartrate) and do not exceed a single dose greater than 11.25 mL (7.5 mg hydrocodone bitartrate).

Doses above these amounts would exceed the maximum doses for adults . Conversion from Other Opioids to Hydrocodone Bitartrate and Acetaminophen Oral Solution There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dosage of hydrocodone bitartrate and acetaminophen oral solution.

It is safer to underestimate a patient’s 24-hour hydrocodone bitartrate and acetaminophen oral solution dosage than to overestimate the 24-hour hydrocodone bitartrate and acetaminophen oral solution dosage and manage an adverse reaction due to overdose. Conversion from Hydrocodone Bitartrate and Acetaminophen Oral Solution to Extended-Release Hydrocodone The relative bioavailability of hydrocodone bitartrate and acetaminophen oral solution compared to extended-release hydrocodone is unknown, so conversion to extended-release hydrocodone may lead to increased risk of excessive sedation and respiratory depression.

Titration and Maintenance of Therapy Individually titrate hydrocodone bitartrate and acetaminophen oral solution to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving hydrocodone bitartrate and acetaminophen oral solution to assess the maintenance of pain control, signs and symptoms of opioid withdrawal, and other adverse reactions, as well as reassessing for the development of addiction, abuse, or misuse [see WARNINGS ].

Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the hydrocodone bitartrate and acetaminophen oral solution dosage.

If after increasing the dosage, unacceptable opioid-related adverse reactions are observed (including an increase in pain after dosage), consider reducing the dosage [see WARNINGS ]. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions. Safe Reduction or Discontinuation of Hydrocodone Bitartrate and Acetaminophen Oral Solution Do not rapidly reduce or abruptly discontinue hydrocodone bitartrate and acetaminophen oral solution in patients who may be physically dependent on opioids.

Patients may also attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances. When a decision has been made to decrease the dose or discontinue therapy in an opioid-dependent patient taking hydrocodone bitartrate and acetaminophen oral solution, there are a variety of factors that should be considered, including the total daily dose of opioid (including hydrocodone bitartrate and acetaminophen oral solution) the patient has been taking, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient.

For patients on hydrocodone bitartrate and acetaminophen oral solution who are physically opioid-dependent, initiate the taper by a small enough increment (e.g., no greater than 10% to 25% of the total daily dose) to avoid withdrawal symptoms, and proceed with dose-lowering at an interval of every 2 to 4 weeks. Patients who have been taking opioids for briefer periods of time may tolerate a more rapid taper.